Prosthesis for supporting a breast structure

ABSTRACT

The invention relates to a prosthesis for supporting a breast implant comprising:a reinforcement part configured to receive a curved lower portion of a breast implant, the reinforcement part having an elongation under 50N in the vertical direction of E1,a fixation part intended to be fixed to the pectoral muscle, the fixation part having an elongation under 50N in the vertical direction of E2, anda transition part connecting together the reinforcement part and the fixation part, said transition part having an elongation under 50N in the vertical direction of E3,wherein E3 is greater than E1 and greater than E2.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/850,063 filed Apr. 16, 2020, which is a divisional of U.S. patentapplication Ser. No. 15/920,597 filed Mar. 14, 2018, now U.S. Pat. No.10,660,741, which is a divisional of U.S. patent application Ser. No.15/099,633 filed Apr. 15, 2016, now U.S. Pat. No. 9,931,198, whichclaims benefit of and priority to European Patent Application No.153056354.6 filed Apr. 24, 2015, the disclosures of each of theabove-identified applications are hereby incorporated by reference intheir entirety.

BACKGROUND 1. Technical Field

The present invention relates to a prosthesis for supporting a breaststructure, such as a breast implant or breast tissue within a patient.

2. Background of Related Art

Breast cancer is one of the most common cancers among women. If thedisease is not caught early, it is common that large portions of breasttissue are removed. In a conventional procedure called mastectomy, oneor both breasts are partially or completely removed in order to treat orsubsequently prevent breast cancer. Since such procedures generallyresult in a substantial amount of tissue being removed, many women willthen opt for breast reconstructive surgery in order to reform the breastinto a natural looking state. It is often acknowledged that the processof cancer treatment and removal of breast tissue can weigh heavily notonly on the patients physical but also emotional well being. Thus, suchsurgery to reconstruct the breast can allow the patient to maintain selfconfidence after such an ordeal.

With reference to FIG. 1 is shown a healthy breast 1. The breast 1 isformed of fat tissue 3 encompassing lobules 4 and milk ducts 5converging towards the nipple-areola complex 2. With reference to FIG. 1, are further shown the infra-mammary fold 6 which defines the lower endof the breast 1, the pectoral muscle 7, the chest wall 8 formed of theribs 9 and of the intercostal muscles 10, and eventually the skin 11.

Within the framework of a mastectomy, lobules 4 and milk ducts 5 areremoved from the breast 1.

SUMMARY

Many techniques of breast reconstruction are known in the art. Suchprocedures generally involve employment of implants, one's own bodytissue, or a combination thereof, which are employed for reforming thebreast. Implants are the most common technique known in the art and areused for reconstructive surgery. This involves the employment ofsilicon, saline, or other suitable material formed implants which may beplaced under the pectoral muscle (submuscular) for forming and shapingthe breast.

With reference to FIG. 2 , is shown a reconstructed breast 1, in whichthe lobules and milk ducts have been removed and replaced by a breastimplant 12 which is placed under the pectoral muscle 7. As shown on thisfigure, the breast implant 12 has the global shape of a water drop witha curve-shaped lower portion and a substantially conical upper portion.

Because of the weakening of the biological tissues around the breastimplant due to mastectomy, it may happen that after some time, thebreast implant bottoms out, in other words moves downwards under theeffect of natural gravity. Such a phenomenon often requires surgery inorder to either remove the implant or reposition it correctly. For thesereasons, implant-based breast reconstruction is usually used incombination with an implantable material intended to provide a layer oflong-term support for the breast implant, for enhanced and shape of thebreast, such implantable material generally having the shape of a slingand acting as an internal bra.

Moreover, independently from medical reasons such as breast cancer, manywomen may decide to undergo breast surgery on a healthy breast in orderto lift up the breast for purely aesthetic reasons. In such a case, nopart of the biological breast tissue is removed, and a material such asa tape or a sling is implanted underneath the breast in order to lift itup and to support it.

The use of medical surgical mesh material as a support member for abreast structure is known in the art. In the present application, by«breast structure» is meant both a breast implant, replacing the removedbiological breast tissue in case of reconstruction of a breast after abreast cancer, or the natural biological breast tissue, in case ofpurely aesthetic surgery. Conventionally, the surgical mesh is providedas a flat substantially rectangular or square sheet that the physicianmust accurately cut to size in an attempt to fit the natural curvatureof a breast and to provide adequate support for the breast structure.

These square or rectangular sheets of mesh fabric are neither configuredto size nor cut to shape to form the proper three dimensional shape whenplaced in a supportive engagement in an arc under the breast implant.Surgeons must take valuable time and cut the fabric sheet in theoperating room during the procedure. In particular, the surgeon must cutthe mesh and use trial by error in order to achieve the bestform-fitting shape. This is time-consuming and fastidious for thesurgeon, and unconfortable for the patient. This need for cutting meshfabric may result in uneven or miss-cut sheets of mesh which are thenimplanted and must be forcefully stretched or manipulated into a“fitted” engagement to the breast of the patient. To maintain thisfitted engagement, the surgeon resorts to sutures through the mesh andinto surrounding tissue. It may also happen that the surgeon has to foldparts of the mesh on itself, thereby creating additional thicknessresulting in an improper fit around the curved area of the breast tissueor implant and possible painful feeling for the patient. Folds may alsocause unnatural appearance.

In addition, the dimensions and configurations of the mesh for eachbreast will vary widely for each instance of the procedure and thedesired outcome of breast size, shape, and form. The lack of customizedsupporting prosthesis for breast implants can adversely effect thefinished shape and feel of the reconstructed breast tissue. Patients maysuffer from discomfort from the material compressing the breast tissueor implant, or from a distaste for the visual aspects of the finishedsurgery. Patients may require further surgeries to correct anyinconsistencies with the mesh, or may just unfortunately live with theuncomfortable current state of the reconstruction.

Moreover, the conventional synthetic mesh materials used today make noprovision for accommodating stretch in one or both directions on acontrolled basis. Known devices may therefore fail in providing adequatesupport and comfort in the natural movement and feel of the breast whichfor each human is of a custom dimension and area. This poor fit and lackof elasticity may result in additional surgeries to correct suchinconsistences.

The stiffness of surgical mesh conventionally employed with breastreconstructive surgery can seriously inhibit the natural look, movement,and feel of the breast tissue and such is undesirable. Further, stiffmaterials formed into meshes can prove more difficult to handle by thephysician during implantation due to the need to customize the planarsheet, to fit the curved three dimensional shape of a breast. Suchmisfitting sheets customized in the operating room may requireadditional suturing to maintain their position in the body.

There is therefore a need for a prosthesis capable of supporting abreast structure, such as a breast implant post mastectomy or thebiological breast tissue in an aesthetic surgery, said breast structurebeing a non planar body having three-dimensional curves, in a mannerthat would be the closest as possible to the natural biological support,regarding on one hand strength of the support in order to avoid saggingof the supported breast structure, and on the other hand elasticity ofsuch support in order to provide a comfortable feeling to the patient.In case the breast structure is a breast implant, there is also a needfor such a supporting prosthesis that would securely hold the breastimplant in order to limit the risk of bottoming out of the implant.There is also a need for a prosthesis for supporting a breast structurethat would allow the surgeon to try several positions of the prosthesisrelative to the breast structure and to the pectoral muscle beforesecure fixation. The prosthesis should therefore be preferablyrepositionable.

In this application, the “upper” end, edge or part of an element of aprosthesis is to be understood as meaning the end, edge or part of theelement located substantially in the direction of the head of the bodywhen the prosthesis is implanted in the body. The “lower” end, edge orpart of an element of a prosthesis is to be understood as meaning theend, edge or part of the element located in the direction of the feet ofthe body when the prosthesis is implanted in the body. Likewise, in thisapplication, the “vertical direction” is to be understood as meaning thedirection aligned on the feet-head axis of a body, and the «horizontaldirection» is to be understood as being the transversal direction of thevertical direction in a plane of the prosthesis.

A first aspect of the invention is a prosthesis for supporting a breaststructure within a patient, the prosthesis comprising:

a reinforcement part comprising a first fabric made of a firstarrangement of biocompatible yarns and configured to receive at least acurve-shaped lower portion of the breast structure, said reinforcementpart being intended to be sutured to the chest wall or to theinfra-mammary fold, said first arrangement of yarns conferring to saidfirst fabric an elongation under 50N in the vertical direction of E1,

a fixation part comprising a second fabric made of a second arrangementof biocompatible yarns and intended to be fixed to the pectoral muscle,said second arrangement of yarns conferring to said second fabric anelongation under 50N in the vertical direction of E2, and

a transition part comprising a third fabric made of a third arrangementof biocompatible yarns, said transition part connecting together thereinforcement part and the fixation part, said third arrangement ofyarns conferring to said third fabric an elongation under 50N in thevertical direction of E3,

wherein E3 is greater than E1 and greater than E2.

In the present application, by arrangement of biocompatible yarns ismeant an assembly of yarns, fibres, filaments and/or multifilamentsforming a fabric, and for example obtained by knitting, weaving,braiding, or non-woven.

In the present application, “biocompatible” is understood as meaningthat the materials having this property can be implanted in the human oranimal body.

The prosthesis of the invention may be provided to the user as a textilein a preformed perimeter shape, said textile encompassing the first,second and third fabrics. The prosthesis of the invention is intended tobe used as a support of a breast structure in breast reconstructivesurgery or in breast lifting surgery and is intended to engage aroundthe breast structure, such as the breast implant or the breast tissue,so as to cup said breast structure, and at least part of its peripheraledge is intended to be sutured either to the chest wall, for example theribs, and/or to the pectoral muscle. The prosthesis of the inventionprovides a shape and configuration providing the most support whencurved in a supportive engagement with the breast structure.

Because of its structure comprising at least three parts and because ofthe relative values of the respective elongations under 50N in thevertical direction of these three parts, the prosthesis of the inventionallows for stretching and elasticity of the supported breast structure,in a manner very close to the natural behavior of a breast, therebyyielding a more natural appearance and movement during movement such aswalking by the patient. The prosthesis of the invention providesexcellent support to the multi directional curves of the supportedbreast structure.

The prosthesis of the invention comprises three parts, one of which, thetransition part, shows an elongation under 50N in the vertical directionE3 greater than the elongation under 50N in the vertical direction E1and E2 of each of the two other parts, namely the reinforcement part andthe fixation part. For example, the value of E3 is above the value of E1and above the value of E2, and E3 may not be equal to E1 and may not beequal to E2.

The elongation under 50N in the vertical direction of each of the threeparts of the prosthesis is provided to said part by the arrangement ofyarns defining the fabric forming said part. In particular, for eachfabric, the elongation under 50N in the vertical direction is dependentboth on the nature of the yarns and on the pattern followed by theyarns. For example, the pattern may be a woven pattern or a knittingpattern. It is known that knits and woven structures possess a warpdirection and a weft direction. For knits and wovens, elongations under50N are measured both in the warp and in the weft directions. Dependingon the weaving or knitting patterns applied and on the nature of theyarns used, the elongation under 50N in the warp direction may bedifferent from the elongation under 50N in the weft direction for asingle fabric.

In the present application, by “elongation under 50N in the verticaldirection” for a fabric of the prosthesis of the invention, is meanteither the elongation under 50N measured in the warp direction of thefabric or the elongation under 50N measured in the weft direction of thefabric, depending on which direction of the fabric, either warp or weft,is positioned along the vertical direction of the prosthesis.

In the present application, the elongation under 50N in the warpdirection and in the weft direction of a fabric is measured according tothe method for measuring the tensile breaking strength and elongation atbreak according to ISO 13934-1: 2013 “Textiles—Tensile properties offabrics—Part 1: Determination of maximum force and elongation at maximumforce using the strip method”, 5 samples, width: 50 mm, Length: 200 mmbetween the jaws, Crosshead speed: 100 mm/min, Pre-load: 0.5 N, using atraction testing machine such as the Hounsfield model H5KS (Hounsfield,Redhill, England).

The reinforcement part of the prosthesis of the invention is intended toreceive the curve-shaped lower portion of a breast implant and isintended to be sutured to the chest wall, for example to the ribs, or tothe infra-mammary fold. The reinforcement part of the prosthesis of theinvention is therefore intended to behave as a hammock and should havemechanical properties sufficient for contributing to the support of thebreast implant against gravity and for example for limiting the risk ofbottoming out of the breast implant. In this view, the first fabricforming the reinforcement part should show an elongation under 50N inthe vertical direction, also referred to as E1, adapted to hold thebreast implant in a relatively steady and reliable manner.

For example, E1 may be equal or less than about 40%. For example E1 mayrange from about 0 to about 40%, preferably from about 18% to about 35%.

The fixation part of the prosthesis of the invention is intended to befixed to the pectoral muscle. The fixation part is intended to face thetop portion of the breast structure and should show mechanicalproperties adapted to secure anchorage of the prosthesis in the pectoralmuscle. In this view, the second fabric forming the fixation part shouldshow a limited elongation under 50N in the vertical direction, alsoreferred to as E2, so that anchorage in the pectoral muscle and tissueingrowth are not negatively impaired by an excessive solicitation.

For example, E2 may be equal or less than about 35%. For example E2 mayrange from about 0% to about 35%, preferably from about 5% to about 15%.

The transition part of the prosthesis of the invention is intended toconnect the reinforcement part to the fixation part so as to absorb thetensions created by the mechanical pressures of the supported breaststructure and limit the pain felt by the patient, and so as to furtherallow the supported breast structure to have the most natural mechanicalbehavior. The transition part may preferably represent a limited area ofthe whole prosthesis and the third fabric forming the transition partshould show an elongation under 50N in the vertical direction, alsoreferred to as E3, adapted to give the supported breast structure somefreedom of movement and to absorb gently the tensions generated in thesupported breast structure by the movements of daily life. Inparticular, E3 is greater than E1 and than E2 so as to have thecapability to absorb the tensions originating from the first fabric andthe second fabric due to the respective functions of support and offixation of the reinforcement part and of the fixation part.

For example, E3 is equal or greater than about 35%. In embodiments, E3ranges from about 35% to about 120%, preferably from about 35% to about70%.

The transition part of the prosthesis of the invention allows theprosthesis to accommodate the curve of the breast structure in a naturaland comfortable fashion for the patient. The elongation under 50N in thevertical direction of the third fabric forming the transition partconfers to the supported breast structure the required elasticity andstretch to allow the breast structure to move in a natural manner whichis comfortable to the patient.

The prosthesis of the invention may be under the form of variousembodiments, for example defined by the following features, taken incombination or as alternatives:

E1 may be equal or less than about 40%, for example E1 may range fromabout 0 to about 40%, preferably from about 18% to about 35%,

E2 may be equal or less than about 35%, for example E2 may range fromabout 0% to about 35%, preferably from about 5% to about 15%,

E3 may be equal or greater than about 35%, for example E3 may range fromabout 35% to about 120%, preferably from about 35% to about 70%,

E3 may be more than 20%, 30%, 50%, 100%, 200% greater than E1,

E3 may be more than 50%, 100%, 200%, 500% greater than E2,

where H represents the total height of the prosthesis and h the heightof the transition part, measured along the vertical direction, when saidprosthesis is in a planar configuration, the ratio h/H ranges from about1/30 to about 1/2, preferably from about 1/12 to about 1/4,

the reinforcement part may have a globally elongated shape in thehorizontal direction, said shape showing a convex lower edge,

the shape of the reinforcement part may show a convex upper edge,

the shape of the reinforcement part may show a concave upper edge,

the transition part may have substantially the shape of a portion of acircular crown,

the lower edge of the shape of the transition part may be the upper edgeof the shape of the reinforcement part,

the fixation part may comprise a lower edge from which extend verticallyand in the upper direction one or more arm(s) intended to be fixed tothe pectoral muscle,

each arm of the fixation part having a lower end and an upper end, saidlower end may be substantially larger in the horizontal direction thansaid upper end,

at least two said arms of the fixation part may extend vertically and inthe upper direction,

at least three said arms of the fixation part may extend vertically andin the upper direction,

at least four said arms of the fixation part may extend vertically andin the upper direction,

at least five said arms of the fixation part may extend vertically andin the upper direction,

at least six said arms of the fixation part may extend vertically and inthe upper direction,

at least seven said arms of the fixation part may extend vertically andin the upper direction,

at least eight said arms of the fixation part may extend vertically andin the upper direction,

the lower edge of the fixation part may be the upper edge of the shapeof the transition part,

a recess may be provided in one or more said reinforcement part,fixation part and transition part, said recess being intended to facethe nipple-areola complex when the prosthesis is implanted,

the first fabric may be a porous knit,

the first fabric may be a two-dimensional porous knit,

the first fabric may be a three-dimensional porous knit,

the first fabric may be a porous knit showing pores having a size above1 mm×1 mm,

the first fabric may show a bursting strength above about 400 kPa,

the yarns forming the first arrangement may be monofilaments,

the yarns forming the first arrangement may be monofilaments having adiameter of less than about 0.3 mm,

the yarns forming the first arrangement may be multifilaments, forexample having a linear density of less than about 400 dTex,

the yarns forming the first arrangement may be surface treated with anlow friction substance,

a face of the first fabric intended to be in contact with the breastimplant may be covered with a low friction coating, for example a lowfriction film,

the first fabric being a three-dimensional porous knit, a face of saidthree-dimensional knit intended to be in contact with the breaststructure may be covered with a low friction coating, for example a lowfriction film, and a face of said three-dimensional knit intended to bein contact with the skin may be provided with pores having a size above1 mm×1 mm,

the height h of the transition part may range from 1 to 5 cm, preferablyfrom 2 to 3 cm,

the third fabric may be a porous knit,

the third fabric may be a two-dimensional porous knit,

the yarns forming the third arrangement may be monofilaments,

the yarns forming the third arrangement may be multifilaments,

the second fabric may be a porous knit,

the second fabric may be a two-dimensional porous knit,

a face of the second fabric intended to face the pectoral muscle may beprovided with fastening means capable of fixing at least temporarilysaid face of said second fabric in the pectoral muscle,

the reinforcement part may be provided with a reinforcement memberconfigured for inducing a curved shape to said first fabric conformablewith said curve-shaped lower portion of the breast structure,

the reinforcement member may be an overmolded wire positioned in thearea of a lower edge of said reinforcement part,

the reinforcement member may be made from a bioresorbable material,

the reinforcement part may be linked to the transition part by means ofsewing, gluing welding, overmolding and combinations thereof,

the transition part may be linked to the fixation part by means ofsewing, gluing, welding, overmolding and combinations thereof,

the first, second and third fabrics may be made as a single unitarystructure,

h being the height of the transition part, h1 being the height of thereinforcement part, h2 being the height of the fixation part, allmeasured along the vertical direction when said prosthesis is in aplanar configuration, the ratio h/h1 may range from about 1/15 to about2/1, preferably from about 1/6 to about 1/1, and the ratio h/h2 mayrange from about 1/15 to about 2/1, preferably from about 1/6 to about1/1.

In embodiments, wherein H represents the total height of the prosthesisand h the height of the transition part, measured along the verticaldirection, when said prosthesis is in a planar configuration, the ratioh/H ranges from about 1/30 to about 1/2, preferably from about 1/12 toabout 1/4. Such a ratio allows obtaining the adequate stretch andelasticity for conferring to the prosthesis a behavior close to thenatural behavior of a natural breast while not jeopardizing the strengthof the support needed to hold the breast structure in place againstgravity. In particular, when the breast structure to be supported is abreast implant, such a ratio contributes to avoid bottoming out of theimplant and sagging of the reconstructed breast.

The required elongation under 50N in the vertical direction may beprovided to each fabric of the prosthesis of the invention by means ofuse of specific yarns such as elastic yarns, which may be combined ornot with conventional non elastic yarns, and/or by means of specificarrangement of yarns, such as the weaving and knitting patterns.

Examples of elastic yarns particularly suitable for the third fabric ofthe prosthesis of the invention may be selected from the groupconsisting in polyether amide yarns, polyurethane yarns or thermoplasticelastomer polyethylene terphthalate yarns, having an elongation at breakequal to or greater than 75%, measured according to ISO 2321:2006.

For example, non elastic yarns may show an elongation at break of lessthan 30% measured according to ISO 2062:2010.

The yarns or fibres or filaments, monofilaments and/or multifilamentsforming the arrangement of yarns constituting the first, second andthird fabrics of the prosthesis according to the invention can be madeof any biodegradable or non-biodegradable biocompatible material.

In the present application, “bioresorbable” or “biodegradable” isunderstood to mean that the materials having this property are absorbedand/or degraded by the tissues or washed from the implantation site anddisappear in vivo after a certain time, which may vary, for example,from a few hours to a few years, depending on the chemical nature of thematerials.

Thus, the biodegradable materials suitable for the yarns of the first,second and third fabrics of the prosthesis according to the presentinvention can be chosen from polylactic acid (PLA), polyglycolic acid(PGA), oxidized cellulose, polycaprolactone (PCL), polydioxanone (PDO),trimethylene carbonate (TMC), polyvinyl alcohol (PVA),polyhydroxyalkanoates (PHAs), copolymers of these compounds and mixturesthereof.

The non-biodegradable materials suitable for the yarns of the first,second and third fabrics of the prosthesis according to the presentinvention can be chosen from polyethylene terephthalate (PET),polyarnides, aramids, expanded polytetrafluoroethylene, polyurethane,polyvinylidene difluoride (PVDF), polybutyl esters, polyetheretherketone(PEEK), polyolefins (such as polyethylene or polypropylene), polyethers,and combinations thereof.

For each fabric, the arrangement of yarns may be a knit, a wovenstructure, a braid or a non-woven. In embodiments, the fabric of thereinforcement part, the fabric of the fixation part and the fabric ofthe transition part of the prosthesis of the invention are knits, inparticular porous knits.

In the present application, the term “porous knit” is intended to mean aknit which has pores, or gaps, alveoli, holes, orifices, which areevenly or unevenly distributed not only at the surface, but also withinthe thickness of said knit. Indeed, by virtue of the meshwork of a knitin general, it is possible to obtain openworked faces that promote cellrecolonization after implantation, namely a porous knit.

For example, the first knit may be a porous knit. The second fabric maybe a porous knit. The third fabric may be a porous knit. In embodiments,each of said first, second and third fabrics are porous knits. Theporous knits suitable for the first, second and third fabrics of theprosthesis of the invention may show various knitting patternsconferring to each knit specific mechanical properties.

The porous knits suitable for the prosthesis of the invention may betwo-dimensional or three-dimensional.

Within the meaning of the present application, a two-dimensional knit isunderstood as a knit having two opposite faces linked to each other bymeshes but devoid of a spacer giving it a certain thickness: such a knitcan be obtained, for example, by knitting yarns on a warp knittingmachine or raschel knitting machine using two guide bars. Examples ofknitting two-dimensional knits suitable for the present invention aregiven in the document WO2009/071998.

According to the present application, a three-dimensional knit isunderstood as a knit having two opposite faces linked to each other by aspacer that gives the knit a significant thickness, said spacer itselfbeing formed from additional linking yarns in addition to the yarnsforming the two faces of the knit. Such a knit can be obtained, forexample, on a double-bed warp knitting or raschel knitting machine usingseveral guide bars. Examples of knitting three-dimensional knitssuitable for the present invention are given in the documentsWO99/05990, WO2009/031035 and WO2009/071998.

The first fabric may be a two-dimensional porous knit. A two-dimensionalknit may confer a good mechanical strength to the first fabric andtherefore to the reinforcement part.

Alternatively, the first fabric may be a three-dimensional porous knit.A three-dimensional porous knit allows a high degree of differentiationof its two opposite faces and therefore allows providing a knit having afirst property on a first face, such as for example a smooth surface forcontact with the breast structure such as a breast implant, and having adifferent property on its opposite face, such as a porosity adapted forpromoting cell growth with regards to the facing skin tissues.

In embodiments, the first fabric is a porous knit showing pores having asize above 1 mm×1 mm. For example, the pore size of the porous knitforming the third fabric may range from 1 mm×1 mm to 3 mm×3 mm.

In the present application, the pore size (width×height) (mm) ismeasured according to the following method: knit biggest pores aremeasured making one measurement on 10 individual samples with a profileprojector such as a projector 300V from ORAMA.

The first fabric forming the reinforcement part is intended to bepositioned between the breast structure and the skin once the prosthesisis implanted. The presence of large pores on the face of the knitforming the first fabric intended to face the skin will favor cellcolonization once the prosthesis is implanted.

In embodiments, the first fabric shows a thickness ranging from 0.2 mmto 2.5 mm. Such a thickness allows the reinforcement part to be lesspalpable under the skin, thereby conferring to the patient a naturalfeeling regarding the supported breast structure.

In embodiments, the first fabric shows a bursting strength above about400 kPa.

In the present application, the bursting strength (kPa) is measuredaccording to ISO 13938-2: 1999 “Textiles—Bursting properties oftextiles—Pneumatic method for determining the bursting strength andbursting deformation”, 5 samples.

Such a bursting strength allows the reinforcement part to completeadequately its function of support. In particular, such a burstingstrength allows the reinforcement part to hold securely the breaststructure, even when the patient performs significant movement of thedaily life, such as jumping, and to compensate the undesired effect ofgravity on the breast structure.

In embodiments, the first fabric shows a suture pull out strength in thewarp direction and in the weft direction above about 15N, preferablyabove about 35N.

In the present application, the suture pull out strength in the warpdirection and in the weft direction is measured according to NF S94-801:2007 “Reinforcement implants introduced by the vaginal route for thetreatment of stress urinary incontinence and/or of prolapse of thepelvic organs—pre-clinical trials and clinical trials”—§ 5.3.3 5specimens 50×100 mm, USP 2 suture yarn, crosshead speed: 100 mm/min,using a traction testing machine such as the Hounsfield model H5KS(Hounsfield, Redhill, England).

Such a suture pull out strength in the warp direction and in the weftdirection allows in particular the reinforcement part to be sutured in areliable manner to the chest wall, for example the ribs, or to theinfra-mammary fold.

In embodiments, the first fabric shows a tear strength in the warpdirection and in the weft direction above about 25N, preferably aboveabout 32N.

In the present application, the tear strength (N) in the warp directionand in the weft direction is measured according to ISO 4674:1977“Textiles covered with rubber or plastic—Determination of the tearstrength” Method A2, 5 samples , width: 75 mm, Tear length ≤145 mm,crosshead speed: 100 mm/min.

Such a tear strength in the warp direction and in the weft directionallows in particular the reinforcement part to resist efficiently totensions generated in the breast structure, in particular in therecontructed breast by the weight of the breast implant.

The yarns forming the first arrangement may be any biocompatible yarnsknown for forming surgical meshes, such as fibers, monofilaments,multifilaments and combinations thereof.

In embodiments, the yarns forming the first arrangement aremultifilaments. Multifilaments may provide a soft touch to the knit andallow obtaining a more natural palpation feeling as well as a morenatural appearance of the supported breast structure.

In embodiments, the yarns forming the first arrangement aremonofilaments. For example, the monofilaments forming the firstarrangement show a diameter of less than about 0.3 mm. Suchmonofilaments with a small diameter are less palpable under the skin andtherefore confer a more natural feeling on the skin of the patient.

A first example of a porous knit suitable for forming a first fabric forthe reinforcement part of the prosthesis of the invention is a knitobtained by knitting a monofilament yarn of polyethylene terephthalateof diameter 0.08 mm on a double bed knitting machine with four guidebars, GBII, GBIII, GBIV and GBV, according to the following pattern,according to ISO 11676 standard:

GBII: 4.3.2.2/ 1.0.1.1/ 1.2.1.1/ 1.0.1.1/ 1.2.1.1/ 1.0.1.1/ 1.2.3.3/4.5.4.4/ 4.3.4.4/4.5.4.4/ 4.3.4.4/ 4.5.4.4//

GBIII: 3.4.8.9/ 6.7.6.6/ 6.5.6.6/ 6.7.6.6/ 6.5.6.6/ 6.7.6.6/ 6.5.1.0/3.2.3.3/ 3.4.3.3/3.2.3.3/ 3.4.3.3/ 3.2.3.3//

GBIV: 4.4.4.3/ 2.2.1.0/ 1.1.1.2/ 1.1.1.0/ 1.1.1.2/ 1.1.1.0/ 1.1.1.2/3.3.4.5/ 4.4.4.3/4.4.4.5/ 4.4.4.3/ 4.4.4.5//

GBV: 1.1.1.2/ 3.3.4.5/ 4.4.4.3/ 4.4.4.5/ 4.4.4.3/ 4.4.4.5/ 4.4.4.3/2.2.1.0/ 1.1.1.2/1.1.1.0/ 1.1.1.2/ 1.1.1.0//

This knit is a three-dimensional knit and will be referred tohereinafter as Knit X.

Knit X shows the following properties, measured according to the methodsas described in the present application:

E1: 25%, corresponding to the elongation under 50N of the knit in thewarp direction of the knit.

Elongation under 50N of the knit in the weft direction: 40%

Bursting strength: 415 kPa

Suture pull out strength in the warp direction and in the weftdirection: 37 N

Tear strength in the warp direction and in the weft direction: 35N

Pore size: 2.1 mm×3.0 mm

Another example of a porous knit suitable for forming a first fabric forthe reinforcement part of the prosthesis of the invention is a knitobtained by knitting a multifilament yarn of polyethylene terephthalateof 50 dTex on a double bed knitting machine with six guide bars, GBI,GBII, GBIII, GBIV, GBV and GBVI, according to the following pattern,according to ISO 11676 standard:

GBI: 1.2.1.1/ 1.0.1.1/ 1.2.1.1/ 1.0.1.1/ 1.2.2.2/ 3.2.2.2/ 1.2.2.2/3.2.2.2//

GBII: 1.2.2.2/ 3.2.2.2/ 1.2.2.2/ 3.2.2.2/ 1.2.1.1/ 1.0.1.1/ 1.2.1.1/1.0.1.1//

GBIII: 0.1.0.1/ 0.0.0.0//

GBIV: 0.1.0.1/ 0.0.0.0//

GBV: 1.1.0.1/ 1.1.2.1/ 1.1.0.1/ 1.1.2.1/ 2.2.2.3/ 2.2.2.1/ 2.2.2.3/2.2.2.1//

GBVI: 2.2.2.3/ 2.2.2.1/ 2.2.2.3/ 2.2.2.1/ 1.1.0.1/ 1.1.2.1/ 1.1.0.1/1.1.2.1//

This knit is a three-dimensional knit and will be referred to hereafteras Knit Y.

Knit Y shows the following properties measured according to the methodsas described in the present application:

E1: 19%, corresponding to the elongation under 50N of the knit in thewarp direction of the knit.

Elongation under 50N of the knit in the weft direction: 44%

Bursting strength: 321 kPa

Suture pull out strength in the warp direction, respectively in the weftdirection: 24N, respectively 33 N.

Tear strength in the warp direction and in the weft direction: 20 N

Pore size: 1.9 mm×2.4 mm

Another example of a porous knit suitable for forming a first fabric forthe reinforcement part of the prosthesis of the invention is a knitobtained by knitting a monofilament yarn of polypropylene of a diameterof 0.10 mm on a double bed knitting machine with four guide bars, GBII,GBIII, GBIV and GBV, according to the following pattern, according toISO 11676 standard:

GBII: 0.1.1.1/ 1.2.2.2/ 3.4.4.4/ 5.4.4.4/ 4.3.3.3/ 2.1.1.1//

GBIII: 5.4.4.4/ 4.3.3.3/ 2.1.1.1/ 0.1.2.1/ 1.2.2.2/ 3.4.4.4//

GBIV: 4.4.5.4/ 4.4.4.3/ 3.3.2.1/ 1.1.0.1/ 1.1.1.2/ 2.2.3.4//

GBV: 1.1.0.1/ 1.1.1.2/ 2.2.3.4/ 4.4.5.4/ 4.4.4.3/ 3.3.2.1//

This knit is a three-dimensional knit and will be referred to hereafteras Knit Z.

Knit Z shows the following properties measured according to the methodsas described in the present application:

E1: 35%, corresponding to the elongation under 50N of the knit in thewarp direction of the knit.

Elongation under 50N of the knit in the weft direction: 45%

Bursting strength: 646 kPa

Suture pull out strength in the warp direction and in the weftdirection: 60 N

Tear strength in the warp direction and in the weft direction: 43 N

Pore size: 1.5 mm×1.5 mm

In embodiments, the yarns forming the first arrangement are surfacetreated with a low friction substance.

Within the meaning of the present application, “low friction” isunderstood as a smooth biocompatible material or coating.

Such embodiments allow obtaining a first fabric showing a low frictionsurface. The contact between the first fabric of the reinforcement partand the breast structure, for example the surface of the breast implant,will therefore be facilitated and will not favor friction, therebylimiting potential erosion with time.

Low friction substance for treating the yarns of the first arrangementmay be selected from silicone, collagen and combinations thereof.Biocompatible spinning oil used in the textile field may also be used asa low friction substance for treating the yarns of the firstarrangement.

Alternatively or in combination, a face of the first fabric intended tobe in contact with the breast structure may be covered with a lowfriction coating, for example a low friction film. Such embodiments willfavor easy contact between the surface of the breast structure, forexample the breast implant and the first fabric and will limit erosionbetween these two elements. Potential degradation of the breaststructure at the contact of the reinforcement part over time willtherefore be avoided or limited.

A low friction film suitable for coating the face of the first fabricintended to be in contact with the breast structure may for example be acollagen film. Films obtained by extrusion from a copolymer ofglycolide, caprolactone, trimethylene carbonate and lactide may also beused as a low friction film for coating the face of the first fabricintended to be in contact with the breast structure.

In embodiments, the first fabric is a three-dimensional porous knit, anda face of said three-dimensional knit intended to be in contact with thebreast structure is covered with a low friction coating, for example alow friction film, and a face of said three-dimensional knit intended tobe in contact with the skin is provided with pores having a size above 1mm×1 mm. Such embodiments allow having different properties on each faceof the knit, each property being in harmony with the function said faceof the knit is intended to perform. The thickness of the threedimensional knit allows differentiating significantly the two oppositefaces of the knit. As such, the face of the knit intended to be incontact with the breast structure is provided with a smooth surfacethanks to the presence of the low friction coating and will enable asmooth contact with the breast structure, for example the breastimplant, limiting the risk of erosion and degradation of the breaststructure over time. Moreover, simultaneously, the large pores of theface of the knit intended to face the skin will favor cell colonizationand cell growth within the three-dimensional knit.

The second fabric, which forms the fixation part, may be atwo-dimensional porous knit. A two-dimensional knit may confer a goodmechanical strength to the second fabric and therefore to the fixationpart.

In particular, for the second fabric, it is possible to use patterns,such as chain stitched patterns, that are known for producing “blocked”knit, in other words knits usually showing a very low elongation atbreak, when only non elastic yarns are used. Such patterns producing“blocked knits” are useful when mechanical properties such as a goodsuture pull out and a good tear strength are needed. Such patternsproduce fabrics having good mechanical resistance and limited elongationunder 50N in the weft and warp directions.

In embodiments, the second fabric is a porous knit showing pores havingsize above 1 mm×1 mm. For example, the pore size of the porous knitforming the second fabric may range from 1 mm×1 mm to 3 mm×3 mm.

The second fabric forming the fixation part is intended to be positionedbetween the breast implant and the pectoral muscle once the prosthesisis implanted. The presence of large pores on the face of the knitforming the second fabric intended to face the pectoral muscle willfavor cell colonization once the prosthesis is implanted.

In embodiments, the second fabric shows a thickness ranging from 0.2 mmto 2.5 mm. Such a thickness allows the fixation part to be less palpableunder the skin, thereby conferring to the patient a natural feelingregarding the supported breast structure.

In embodiments, the second fabric shows a suture pull out strength inthe warp direction and in the weft direction above about 20 N,preferably above about 30 N.

Such a suture pull out strength in the warp direction and in the weftdirection allows in particular the fixation part to be sutured in areliable manner to the pectoral muscle.

In embodiments, the second fabric shows a tear strength in the warpdirection and in the weft direction above about 15 N, preferably aboveabout 18 N.

Such a tear strength in the warp direction and in the weft directionallows in particular the fixation part to resist efficiently to tensionsgenerated into said fixation part by the effect of gravity on the breaststructure.

In embodiments, a face of said second fabric intended to face thepectoral muscle is provided with fastening means capable of fixing atleast temporarily said face of said second fabric in the pectoralmuscle. For example, these fastening means are barbs protruding from theface of the second fabric intended to be positioned in regards of thepectoral muscle.

These fastening means or barbs can protrude from said face of saidsecond fabric in a manner substantially perpendicular to the plane ofsaid face or, alternatively, in one or more planes inclined with respectto the plane of said face. These barbs are intended to function asfixing means by anchoring themselves in the pectoral muscle.

By virtue of the fastening means, such as barbs, the second fabric ofthe prosthesis of the invention fixes naturally at least temporarily tothe pectoral muscle. In particular, the surgeon may grip and ungrip thesecond fabric to the pectoral muscle as many times as necessary until hedetermines, optionally with the help of the patient, the right positionfor the fixation.

The fastening means, for example the barbs, of the second fabric of theprosthesis according to the invention can be formed from yarns, forexample hot-melt monofilament yarns issuing directly from thearrangement of yarns forming the fabric. Fabrics and barbs of this kind,and the method of producing them, are described, for example, in theapplications WO01/81667 and DE 198 32 634 or in the patents U.S. Pat.Nos. 6,596,002 and 5,254,133.

For example, the barbs are formed from monofilament yarns made ofpolylactic acid.

Alternatively, the fastening means, for example the barbs, of the secondfabric of the prosthesis according to the invention can be any kind ofhook made entirely from biocompatible material and integral with thearrangement of yarns forming said fabric, irrespective of whether thesehooks have been incorporated in said fabric during the manufacture(braiding, knitting, weaving, etc.) of said arrangement of yarns or havebeen attached later.

Knits with barbs suitable for the second fabric of the prosthesis of thepresent invention are described in WO01/81667, for example, or are alsocommercially available from the company Sofradim Production under thetrade name Parietex® Progrip or Parietene® Prog rip.

In one embodiment, the second fabric is a knit based on at least a firstyarn of biocompatible polymer material defining a first and second facesof the second fabric and at least a second biocompatible hot-meltmonofilament yarn forming said fastening means by melting of loopsgenerated by said second yarn, the pattern followed for knitting saidfirst and second yarns on a warp knitting machine with three guide barsB1, B2, B3 being the following, according to the standard ISO 11676:

Bar B1: 1.0/0.1//

Bar B2: 1.0/7.7/6.6/7.7//

Bar B3: 2.1/5.5/3.4/0.0//

said second yarn following the pattern chart of bar B3.

This knit is a two-dimensional knit and will be referred to as Knit F.Knit F shows the following properties:

E2: 5%, corresponding to the elongation under 50N of the knit in thewarp direction.

Elongation under 50N of the knit in the weft direction: 15%

Suture pull out strength in the warp direction and in the weftdirection: 44 N in the warp direction, and 30 N in the weft direction

Tear strength in the warp direction and in the weft direction: 28 N inthe warp direction and 18 N in the weft direction

Pore size: 1.8 mm×1.8 mm

The third fabric, which forms the transition part, may be atwo-dimensional porous knit. A two-dimensional knit may confer a goodmechanical strength to the second fabric and therefore to the transitionpart.

In embodiments, the third fabric shows an elongation under 50 N in thewarp direction equal or greater than about 35%. In embodiments, thethird fabric shows an elongation under 50 N in the warp directionranging from about 35% to about 120%.

In embodiments, the third fabric shows an elongation under 50 N in theweft direction equal or greater than about 35%. In embodiments, thethird fabric shows an elongation under 50 N in the weft directionranging from about 35% to about 120%.

Such elongation under 50 N in the weft direction and in the warpdirection allow the third fabric to show an elongation under 50 N in thevertical direction of at least 35% and to confer to the transition partthe required elasticity and stretch to perform its function of absorbingthe tensions generated by the supported breast structure.

In embodiments, the third fabric is a porous knit showing pores having asize above 1 mm×1 mm. For example, the pore size of the porous knitforming the third fabric may range from 1 mm×1 mm to 3 mm×3 mm.

The third fabric forming the transition part is intended to bepositioned between the breast structure and a lower region of thepectoral muscle once the prosthesis is implanted. The presence of largepores on the face of the knit forming the third fabric intended to facethe lower region of the pectoral muscle will favor cell colonizationonce the prosthesis is implanted.

In embodiments, the third fabric shows a tensile breaking strength inthe warp direction and in the weft direction equal or greater than 115N. In embodiments, the third fabric shows a tensile breaking strength inthe warp direction and in the weft direction ranging from 115 N to 350N.

In the present application, the tensile breaking strength in the warpdirection and in the weft direction is measured according to thefollowing method: Tensile breaking strength and elongation at break: ismeasured according to ISO 13934-1: 2013 “Textiles—Tensile properties offabrics—Part 1: Determination of maximum force and elongation at maximumforce using the strip method”, 5 samples, width: 50 mm, Length: 200 mmbetween the jaws, Crosshead speed: 100 mm/min, Pre-load: 0.5 N, using atraction testing machine such as the Hounsfield model H5KS (Hounsfield,Redhill, England).

Such a tensile breaking strength in the warp direction and in the weftdirection allows the transition part to complete adequately its functionof support.

In embodiments, the third fabric shows a thickness ranging from 0.2 mmto 2.5 mm. Such a thickness allows the transition part to be lesspalpable under the skin, thereby conferring to the patient a naturalfeeling regarding the supported breast structure.

In embodiments, the yarns forming the third arrangement aremonofilaments. Monofilaments allow obtaining a more natural appearanceof the reconstructed breasts and also a more natural palpation feeling.Such monofilaments are less palpable and therefore confer a more naturalfeeling on the skin of the patient.

Elastic yarns may be used to provide the required elongation under 50Nin the vertical direction for the third fabric. Alternatively or incombination, the weaving pattern or the knitting pattern may provide therequired elongation under 50N in the vertical direction for the thirdfabric.

A first example of a porous knit suitable for forming a third fabric forthe transition part of the prosthesis of the invention is atwo-dimensional porous knit as described in WO2011/042811, namelyobtained by knitting a monofilament of polyethylene terephthalate ofdiameter 0.08 mm on a warp knitting machine having two guide bars B1,B2, according to the following pattern, according to the ISO 11676standard:

Bar B1: 1.0/1.2/1.0/2.3/2.1/2.3/4.5/4.3/4.5/3.2/3.4/3.2//

Bar B2: 4.5/4.3/4.5/3.2/3.4/3.2/1.0/1.2/1.0/2.3/2.1/2.3//

Guide bars B1 and B2 are threaded 1 full 1 empty and move symmetrically.

This knit will hereinafter be referred to as Knit A.

Another example of a porous knit suitable for forming a third fabric forthe transition part of the prosthesis of the invention is atwo-dimensional knit as described in U.S. 6,408,656, namely obtained byknitting a monofilament of polypropylene of diameter 0.10 mm on a warpknitting machine having two guide bars B1, B2, according to thefollowing pattern, according to the ISO 11676 standard:

Bar B1: 5.4/4.3/2.1/0.1/1.2/3.4//

Bar B2: 0.1/1.2/3.4/5.4/4.3/2.1//

Guide bars B1 and B2 are threaded 1 full 1 empty and move symmetrically.

This knit will hereinafter be referred to as Knit B.

Another example of a porous knit suitable for forming a third fabric forthe transition part of the prosthesis of the invention is atwo-dimensional knit obtained by knitting a monofilament ofpolypropylene of diameter 0.12 mm knitted on a warp knitting machinehaving two guide bars B1, B2, the pattern followed being the following,according to the ISO 11676 standard:

Bar B1: 1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//

Bar B2: 4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//

Guide bars B1 and B2 are threaded 1 full 1 empty and move symmetrically.

This knit will hereinafter be referred to as Knit C.

The properties of Knits A, B and C measured according to the measuringmethods described hereinabove are collected in the following table:

Knit A Knit B Knit C Warp Weft Warp Weft Warp Weft Tensile breaking 175± 12 129 ± 2 187 ± 16 149 ± 10 237 ± 6 201 ± 6 strength (N) Elongationunder 54 ± 0  50 ± 6 43 ± 1 59 ± 1  38 ± 1  46 ± 0 50 N (%) Thickness(mm) 0.4 0.4 0.6 Pore size (mm) 1.5 × 1.5 1.6 × 1.4 2.0 × 2.4 (width ×height)

In embodiments, depending on which direction, warp or weft, may beselected to position Knit A as the third fabric of the prosthesis of theinvention with respect to the vertical direction, E3 may either be 54%or 50%. In other embodiments, depending on which direction, warp orweft, may be selected to position Knit B as the third fabric of theprosthesis of the invention with respect to the vertical direction, E3may either be 43% or 59%. In other embodiments, depending on whichdirection, warp or weft, may be selected to position Knit C as the thirdfabric of the prosthesis of the invention with respect to the verticaldirection, E3 may either be 38% or 46%.

The reinforcement part is intended to receive the curve-shaped lowerportion of a breast structure. In embodiments, the reinforcement parthas a globally elongated shape in the horizontal direction, said shapeshowing a convex lower edge. Said shape may show a convex upper edge.Alternatively, said shape may show a concave upper edge.

The first fabric forming the reinforcement part of the prosthesisaccording to the invention may preferably have a generally elongateshape, for example oval or elliptic. The first fabric can have anotherinitial shape and can then be cut to such an elongate shape, inparticular to a shape adapted to the function of the reinforcement part.In particular, the shape of the first fabric of the prosthesis of theinvention comprises a part capable of efficiently receiving thecurved-shape lower portion of a breast structure. The first fabric isessentially delimited by a lower edge and an upper edge. The lower edgeis preferably convex in order to optimize the conformity of the firstfabric with the curved shape of the lower portion of the breaststructure and the suturability of said first fabric to the chest wall.As such, the general shape of the lower edge is preferably convex.

In embodiments, the reinforcement part is provided with a reinforcementmember configured for inducing a curved shape to said first fabricconformable with said curve-shaped lower portion of the breaststructure. Such embodiments limit the risk of undesired pleating thatmay occur when implanting a textile over a rounded breast implant.

The reinforcement member may be a rigid or semi-rigid wire having aresiliency or elasticity allowing it to be deformed under the effect ofa temporary stress. According to the present invention, thereinforcement member may have an initial curved state allowing the firstfabric, and therefore the reinforcement part, to adopt a shapeconformable to the curved shape of the lower portion of the breaststructure.

The reinforcement member, such as a wire, of the prosthesis according tothe invention may be substantially set back from the lower edge of thereinforcement part/first fabric.

The materials that may be suitable for producing the reinforcementmember of the prosthesis according to the invention may be chosen fromany biocompatible material having a certain rigidity and a certainresilience in order to meet the requirements described above.

In one embodiment, the reinforcement member, for example the wire, ismade of a bioresorbable material. For example, the bioresorbablematerial can be chosen from among polylactic acid (PLA),polycaprolactones (PCL), polydioxanones (PDO), trimethylene carbonates(TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHA), oxidizedcellulose, polyglycolic acid (PGA), copolymers of these materials andmixtures thereof. For example, the bioresorbable material can be acopolymer of polylactic acid and of polyglycolic acid.

Alternatively, the reinforcement member of the prosthesis according tothe invention is made of a non-bioresorbable material chosen from amongpolypropylenes, polyesters such as polyethyleneterephthalates,polyarnides, silicones, polyether ether ketone (PEEK), polyether ketoneketone (PEKK), polyarylether ether ketone (PAEK), polyurethanes andmixtures thereof.

In another embodiment, said reinforcement member is formed by acombination of bioresorbable material and of non-bioresorbable material.

In one embodiment, the reinforcement member of the prosthesis accordingto the invention is an overmolded wire positioned in the area of a loweredge of said reinforcement part.

The reinforcement member may also be used to help suturing thereinforcement part to the chest wall or to the infra-mammary fold.

The transition part connects the reinforcement part to the fixationpart. In embodiments, the transition part has substantially the shape ofa portion of a circular crown. For example, a lower edge of said portionof a circular crown is also said upper edge of said shape of saidreinforcement part.

In embodiments, the height h of the transition part ranges from 1 to 5cm, preferably from 2 to 3 cm. Such embodiments allow providing to theentire prosthesis an elasticity and stretch allowing it to behavesimilarly to biological breast tissues, while not jeopardizing thetensile strength necessary to the prosthesis for performing its supportfunction.

The fixation part is intended to be fixed to the pectoral muscle. Inembodiments, said fixation part comprises a lower edge from which extendvertically and in the upper direction one or more arm(s) intended to befixed to the pectoral muscle. Each arm having a lower end and an upperend, said lower end may be substantially larger in the horizontaldirection than said upper end. Each arm may therefore have asubstantially triangular shape. In embodiments, at least two said armsextend vertically and in the upper direction. For example, at leastthree said arms may extend vertically and in the upper direction. Inembodiments, at least four said arms extend vertically and in the upperdirection. For example, at least five said arms extend vertically and inthe upper direction. In embodiments, at least six, seven or eight saidarms extend vertically and in the upper direction.

The number of arm(s), their position and their shape allow inducing aconical shape to the fixation part. In particular, the surgeon does notneed to cut the second fabric in order to arrange the fabric in aconical manner. Indeed, thanks to the lower end of each arm beingsubstantially larger in the transverse direction than its upper end, thesurgeon can easily form a conical mesh that conforms to the conical-likeshape of the top of the breast structure.

In embodiments, said lower edge of said second fabric is also an upperedge of said portion of a circular crown.

In embodiments, the reinforcement part is linked to the transition partby means of sewing, gluing, welding, overmolding and combinationsthereof. Alternatively, the reinforcement part and the transition part,and in particular the first fabric and the third fabric, may be made asa single structure. In embodiments, the transition part is linked to thefixation part by means of sewing, gluing welding, overmolding andcombinations thereof. Alternatively, the transition part and thefixation part, and in particular the second fabric and the third fabric,may be made as a single structure.

Alternatively, the reinforcement part, the transition part and thefixation part, and in particular the first, second and third fabrics,are made as a single unitary structure. For example, using a knittingmachine and the proper knitting pattern and/or yarn, the wholeprosthesis, namely the reinforcement part, fixation part and transitionpart, and more particularly the first, second and third fabrics may beknitted and formed as a single unitary structure requiring no sewing orcutting. Such embodiment allows a very natural appearance as significantthickness variations or fabric ridges are thereby avoided.

In embodiments, a recess is provided in one or more of saidreinforcement part, fixation part and transition part, said recess beingintended to face the nipple-areola complex when the prosthesis isimplanted. Such embodiments allow preserving the nipple-areola complexwhen a prosthesis of the invention is implanted in order to lift upbreast tissue. Moreover, such embodiment allows facilitating thereconstruction of the nipple-areola complex further to the implantationof a breast implant and of the prosthesis of the invention. Indeed, thereconstruction of the nipple-areola complex usually takes place once thebreast implant and the prosthesis of the invention are implanted and forexample once cell colonization has already taken place. The presence ofthe recess in the prosthesis of the invention avoids an additionalthickness in the area of the nipple-areola complex and leaves free saidarea. The surgeon does not have to take the prosthesis into account inthis area when he proceeds to the reconstruction of the nipple-areolacomplex.

The prosthesis of the invention may be provided in a kit of prosthesispieces, with each of the plurality of prosthesis pieces in the kit beingof varying sizes (sizes may include small, medium, large, etc. . . . ormay conform to well known bra sizes).

A second aspect of the present invention is a method for implanting aprosthesis of the invention for supporting a breast structure, such as abreast implant or breast tissue, comprising the following steps:

a) making an incision in the area of the infra-mammary fold,

b) if a breast implant is needed, positioning said breast implantbetween the chest wall and the pectoral muscle after desinsertion of thepectoral muscle,

c) positioning the prosthesis described above so that the curve-shapedlower portion of the breast structure is received in the reinforcementpart, with a lower edge of the reinforcement part facing the chest wall,and an upper area of the fixation part facing the pectoral muscle,

d) suturing the lower edge of the reinforcement part to the chest wallor to the infra-mammary fold,

e) determining the best position of the fixation part with respect tosaid pectoral muscle,

f) fixing the fixation part to the pectoral muscle,

g) closing the incision.

For example, step e) may be completed by gripping and ungripping saidfixation part as many times as necessary with the help of the barbs ofsaid second fabric.

The method of the invention may be used in case of a reconstruction of abreast post mastectomy or for an oncoplastic surgery as a mastopexy postlumpectomy. The method of the invention may also be used for lifting uphealthy breast tissue in pure aesthetic surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

The prosthesis and method of the invention will now be further describedin reference to the following description and attached drawings inwhich:

FIG. 1 is a side view of a healthy breast,

FIG. 2 is a side view of a reconstructed breast comprising a breastimplant only,

FIG. 3 is a front view of a first embodiment of a prosthesis accordingto the invention,

FIG. 4 is a front view of a second embodiment of a prosthesis accordingto the invention,

FIG. 5 is a front view of a third embodiment of a prosthesis accordingto the invention,

FIG. 6 is a front view of a fourth embodiment of a prosthesis accordingto the invention,

FIG. 7 is a front view of a fifth embodiment of a prosthesis accordingto the invention,

FIG. 8 is a front view of a sixth embodiment of a prosthesis accordingto the invention,

FIG. 9 is a front view of a seventh embodiment of a prosthesis accordingto the invention,

FIG. 10 is a side view of a prosthesis of FIGS. 3-9 implanted within apatient for supporting a breast implant,

FIG. 11 is a front view of another embodiment of a prosthesis accordingto the invention,

FIG. 12 is a side view of the prosthesis of FIG. 11 implanted within apatient for supporting breast tissue.

DETAILED DESCRIPTION OF THE EMBODIMENTS

With reference to FIGS. 3-8 are shown embodiments of a prosthesis 100 ofthe invention. As will appear from the description below, the prosthesis100 is intended to be implanted into a female patient in a view ofsupporting a breast implant 12 (see FIG. 10 ) in breast reconstructionpost mastectomy or in a view of supporting breast tissue (see FIGS. 11and 12 ) in breast lifting aesthetics surgery.

With reference to FIGS. 3-8 , the prosthesis 100 comprises three parts,a reinforcement part 101, a fixation part 102 and a transition part 103.The reinforcement part 101 is configured to receive at least acurve-shaped lower portion of a breast structure and is intended to besutured to the chest wall or to the infra-mammary fold. The fixationpart 102 is intended to be fixed to the pectoral muscle. The fixationpart 102 will usually be surrounding the top conical portion of thebreast structure (see FIGS. 10 and 11 ). The transition part 103connects the reinforcement part 101 to the fixation part 102.

With reference to FIGS. 3-8 the reinforcement part 101 has a globallyelongated shape in the horizontal direction, said shape showing a convexlower edge 104. The shape of the reinforcement part 101 is suited toengage over the lower or bottom curve portion of a breast structure in amanner to cup or otherwise support the structure in a bra-like fashion.The reinforcement part 101 will form the bottom part of the prosthesisand its lower edge is substantially an arch shaped perimeter edge, usinga predetermined depth or arc corresponding to the natural shape ofbreast.

The convex lower edge 104 of the reinforcement part therefore allowsencompassing the lower portion of a breast structure while remainingclose to the chest wall or to the infra-mammary fold. As will appearlater in the description, the lower edge 104 of the reinforcement part101 is intended to be sutured or fixed to the chest wall or to theinfra-mammary fold once the prosthesis 100 is implanted.

For example, the shape of the reinforcement part 101 may be generallyoval or elliptical as shown on FIGS. 5-7 . In such a case, the shape ofthe reinforcement part shows a convex upper edge 105.

Alternatively, the shape of the reinforcement part 101 may show aconcave upper edge 105, as shown on FIGS. 3, 4 and 8 . For example, thereinforcement part 101 may have a crescent shape, as shown on FIGS. 3and 4 . With reference to FIG. 8 , the concave upper edge 105 of thereinforcement part 101 may show an additional concave curve 108.

With reference to FIG. 9 , the fabric used for forming the reinforcementpart 101 may have another initial shape and can then be cut to such anelongate shape, in particular to a shape adapted to the function of thereinforcement part.

With reference to FIGS. 3-9 , the transition part 103 connects thereinforcement part 101 to the fixation part 102. The transition part 103may have substantially the shape of a portion of a circular crown. Inparticular, the transition part 103 shows a height h (see FIG. 6 ) inthe vertical direction substantially constant. In this view, the loweredge 106 and the upper edge 107 of the transition part 103 aresubstantially parallel to each other.

Indeed, as will appear later in the description, the transition part 103possesses an elongation greater than the elongation of the reinforcementpart 101 and of the fixation part 102, so that stretch and elasticityclose to the natural behavior of a healthy breast is conferred to thesupported breast structure. In this view, having a substantiallyconstant height h of the transition part 103 allows maintaining arelatively constant stretch feeling along the horizontal direction ofthe prosthesis 100, and therefore of the supported breast structure.

For example, the lower edge 106 of the portion of a circular crownforming the transition part 102 is also the upper edge 105 of thereinforcement part 101. With reference to FIGS. 3, 4, 8 and 9 , thelower edge 106 and the upper edge 107 of the transition part 103 showtherefore a concave shape. With reference to FIG. 8 , the lower edge 106and the upper edge 107 of the transition part 103 are not substantiallyparallel as the lower edge 106 of the transition part 103 comprises theconcave curve 108, whereas the upper edge 107 does not include anyadditional curve.

On the contrary, with reference to FIGS. 5-7 , the lower edge 106 andthe upper edge 107 of the transition part 103 show therefore a convexshape.

In embodiments, H represents the total height of the prosthesis 100 andh the height of the transition part 103, along a vertical direction,when the prosthesis 100 is in a planar configuration, for example asshown on FIG. 6 , the ratio h/H ranges from about 1/30 to about 1/2,preferably from about 1/12 to about 1/4.

In embodiments, the height h of the transition part ranges from 1 to 5cm, preferably from 2 to 3 cm.

Such embodiments allow providing to the entire prosthesis an elasticityand stretch allowing it to behave similarly to biological breasttissues, while not jeopardizing the mechanical properties necessary forthe prosthesis to perform its support function.

The fixation part 102 forms the upper part of the prosthesis 100 and isintended to be fixed to the pectoral muscle once the prosthesis 100 isimplanted (see FIGS. 10 and 11 ). The fixation part 102 may have anyshape as long as said shape provides sufficient surface for overlappingan area of the pectoral muscle sufficient for ensuring a reliablefixation between the fixation part 102 and the pectoral muscle. Forexample, with reference to FIGS. 3-9 , the fixation part 102 comprises alower edge 109 from which extend vertically and in the upper directionone or more arm(s) 110 intended to be fixed to the pectoral muscle.

The arms 110 have a lower end 111 and an upper 112. Preferably, thelower 111 is larger in the horizontal direction than the upper 112, inorder to ensure better resistance against gravity and better fixation.With reference to FIGS. 8 and 9 , the lower ends 111 of the arms 110form a continuous strip 113.

With reference to FIGS. 3 and 5 , two arms 110 extend from the loweredge 109 of the fixation part 102 in the upper direction. With referenceto FIGS. 4, 7 and 8 , four arms 110 extend from the lower edge 109 ofthe fixation part 102 in the upper direction. With reference to FIGS. 6and 9 , five 110 extend from the lower edge 109 of the fixation part 102in the upper direction.

The number of arms 110 may be varying from one up to ten, as long assaid arms provide the necessary surface and strength for ensuring areliable fixation to the pectoral muscle.

In addition, the shape and number of arms 110 allow shaping the fixationpart 102 in a three-dimensional manner, in order to conform to theconical shape of the top portion of the breast structure. Thanks to thesubstantially triangular shape of the arms 110 and to their numberpreferably greater than one, pleats are avoided when the surgeon shapesthe fixation part 102 in conformity with the three dimensional shape ofthe breast structure.

With reference to FIGS. 5, 7 and 9 is shown a recess 114 provided in theprosthesis. The recess 114 may be provided in the transition part 103(see FIG. 9 ) or may be part of the fixation part 103 and of thetransition part 102 as shown on FIGS. 5 and 7 . The recess 114 isintended to face the nipple-areola complex when the prosthesis 100 isimplanted. The presence of the recess 114 in the prosthesis 100 avoidsan additional thickness in the area of the nipple-areola complex andleaves free this area when the surgeon proceeds to the reconstruction ofnipple-areola complex if needed.

With reference to FIGS. 7 and 8 is shown a reinforcement member underthe form of a wire 115, provided in the lower region of thereinforcement part 101. The wire 115 is configured for inducing a curvedshape to the reinforcement part 101 conformable with the curve-shapedlower portion of the breast structure. The wire 115 is substantially setback from the lower edge of the reinforcement part 101.

The materials that may be suitable for producing the wire 115 may bechosen from any biocompatible material having a certain rigidity and acertain resilience in order to meet the requirements described above.

In one embodiment, the wire is made of a bioresorbable material. Forexample, the bioresorbable material can be chosen from among polylacticacid (PLA), polycaprolactones (PCL), polydioxanones (PDO), trimethylenecarbonates (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHA),oxidized cellulose, polyglycolic acid (PGA), copolymers of thesematerials and mixtures thereof. For example, the bioresorbable materialcan be a copolymer of polylactic acid and of polyglycolic acid. Suchembodiments allow avoiding that foreign material stay too long a time inthe body of the patient.

Alternatively, the wire 115 may be made of a non-bioresorbable materialchosen from among polypropylenes, polyesters such aspolyethyleneterephthalates, polyarnides, silicones, polyether etherketone (PEEK), polyether ketone ketone (PEKK), polyarylether etherketone (PAEK), polyurethanes and mixtures thereof. Additional support istherefore provided on a long term basis to the prosthesis 100 forholding the breast implant against gravity.

In another embodiment, said reinforcement member is formed by acombination of bioresorbable material and of non-bioresorbable material.

The wire 115 may be overmolded on the reinforcement part 101.

In embodiments, the reinforcement part 101 is linked to the transitionpart 103 by means of sewing, gluing, welding, overmolding andcombinations thereof. In embodiments, the transition part 103 is linkedto the fixation part 102 by means of sewing, gluing welding, overmoldingand combinations thereof.

Alternatively, the first, second and third fabrics forming thereinforcement part, the transition part and the fixation part are madeas a single unitary structure. For example, using a knitting machine andthe proper knitting pattern and/or yarn, the whole prosthesis, namelythe reinforcement part, fixation part and transition part, and moreparticularly the first, second and third fabrics may be knitted andformed as a single unitary structure requiring no sewing or cutting.Such embodiment allows a very natural appearance as significantthickness variations or fabric ridges are thereby avoided.

The reinforcement part 101 of FIGS. 3-9 comprises, or may consist in, afirst fabric made of a first arrangement of yarns as described above inthe present application, with in particular an elongation under 50N inthe vertical direction referred to as E1. The fixation part 102 of FIGS.3-9 comprises, or may consist in, a second fabric made of a secondarrangement of yarns as described above in the present application, within particular an elongation under 50N in the vertical direction referredto as E2. The transition part 103 of FIGS. 3-9 comprises, or may consistin, a third fabric made of a third arrangement of yarns as describedabove in the present application, with in particular an elongation under50N in the vertical direction referred to as E3.

For each prosthesis 100 of FIGS. 3-9 , the first, second and thirdfabrics are combined together so as to form the reinforcement part, thefixation part and the transition part, with the proviso that E3 isgreater than E1 and greater than E2.

For example, for a prosthesis 100 of FIGS. 3-8 , the reinforcement part101 may be formed of Knit X described above, in combination with thefixation part 102 made of Knit F described above and with the transitionpart 103 made of Knit A described above. In such an embodiment, E1 is25%, E2 is 5% and E3 is 50%.

In another example, for a prosthesis 100 of FIGS. 3-8 , thereinforcement part 101 may be formed of Knit Y described above, incombination with the fixation part 102 made of Knit F described aboveand with the transition part 103 made of Knit B described above. In suchan embodiment, E1 is 19%, E2 is 5% and E3 is 59%.

In another example, for a prosthesis 100 of FIGS. 3-8 , thereinforcement part 101 may be formed of Knit Z described above, incombination with the fixation part 102 made of Knit F described aboveand with the transition part 103 made of Knit C described above. In suchan embodiment, E1 is 35%, E2 is 5% and E3 is 46%.

With reference to FIG. 10 is shown a prosthesis 100 of FIGS. 3-9 inplace within a patient in a view of supporting a breast implant 12. Asshown on this Figure, the lower edge 104 of the reinforcement part 101of the prosthesis 100 is sutured to the chest wall 8 by means of suture200. Alternatively, the lower edge 104 of the reinforcement part 101 ofthe prosthesis 100 could be sutured to the infra-mammary fold 6. Thereinforcement part 101 receives the lower curved portion of the breastimplant 12 so as to cup said breast implant 12.

The fixation part 102 faces the pectoral muscle 7. In particular, in thesurgical procedure shown, the implant breast 12 is positioned behind thepectoral muscle 7. The second fabric forming the fixation part 102 isprovided with barbs 116 on its face fixed to the pectoral muscle 7.

With reference to FIG. 11 is shown another prosthesis 100 of theinvention, comprising a reinforcement part 101, a fixation part 102 anda transition part 103. The fixation part 102 is provided with two arms110. The prosthesis 100 is further provided with a recess 114 intendedto face nipple-areola complex. In the prosthesis of FIG. 11 , the recess114 is located in the reinforcement part 101. Such a prosthesis isparticularly adapted for lifting up healthy breast tissue in pureaesthetic surgery.

With reference to FIG. 12 is shown the prosthesis 100 of FIG. 11 inplace within a patient in a view of supporting a healthy breast 1. Nopart of the healthy breast 1 has been removed and the lobules 4 and themilk ducts 5 are still present and received within the reinforcementpart 101 of the prosthesis 100. As shown on this Figure, the lower edge104 of the reinforcement part 101 of the prosthesis 100 is sutured tothe chest wall 8 by means of suture 200. Alternatively, the lower edge104 of the reinforcement part 101 of the prosthesis 100 could be suturedto the infra-mammary fold 6. The reinforcement part 101 receives thelower curved portion of the breast 1 so as to cup said breast 1.

The fixation part 102 faces the anterior face of the pectoral muscle 7.The second fabric forming the fixation part 102 is provided with barbs116 on its face fixed to the anterior face of the pectoral muscle 7. Therecess 114 is positioned facing the nipple-areola complex 2 so as topreserve it.

In order to implant the prosthesis 100 of the invention, the surgeon mayperform the following steps:

a) making an incision in the area of the infra-mammary fold 6,

b) if needed, for example in breast reconstruction surgery, positioningthe breast implant 12 between the chest wall 8 and the pectoral muscle7,

c) positioning the prosthesis 100 so that the curve-shaped lower portionof the breast implant 12 or of the breast tissue is received in thereinforcement part 101, with the lower edge 104 of the reinforcementpart 101 facing the chest wall 8, and an upper area of the fixation part102 facing the pectoral muscle 7,

d) suturing the lower edge 104 of the reinforcement part 101 to thechest wall 8, for example by means of suture 200,

e) determining the best position of the fixation part 102 with respectto the pectoral muscle 8,

f) fixing the fixation part 102 to the pectoral muscle 7,

g) closing the incision.

For example, step e) may be completed by gripping and ungripping thefixation part 102, in particular the arms 110, as many times asnecessary with the help of the barbs 116 present on the second fabricforming the fixation part 102. The barbs 116 may show a free end or headgreater in width than a body of the barbs and a generally spheroidal ormushroom shape. The head of the barbs 116 are capable of penetrating inthe pectoral muscle 7 for gripping each arm 110 to the pectoral muscle7. The surgeon may examine whether the position of the arms 110 iscorrect or not. If the surgeon evaluates that the position should becorrected, he simply ungrips the arms 110 and proceeds to a secondgripping of the arms 110 into the pectoral muscle 7. Thanks to thepresence of the barbs 116, the fixation part 102 is repositionable. Inaddition, the determination of the adequate fixation position may becompleted with the help of patient in a standing or seating position.

Because of its structure comprising at least three parts and because ofthe relative values of the respective elongations under 50N in thevertical direction of these three parts, the prosthesis of the inventiononce implanted in view of supporting a breast structure, allows forstretching and elasticity of the supported breast structure, in a mannervery close to the natural behavior of a breast, thereby yielding a morenatural appearance and movement during movement such as walking by thepatient. The prosthesis of the invention further provides excellentsupport to the multi directional curves of the supported breaststructure.

The structure of the prosthesis of the invention allows both efficientsupport to avoid sagging and bottoming out of the breast structure suchas a breast implant and adequate elasticity for natural feel andmovement. The prosthesis of the invention further supports the breaststructure in the proper orientation.

What is claimed is:
 1. A method for implanting a prosthesis forsupporting a breast structure comprising: a) making an incision in anarea of an infra-mammary fold, b) optionally, positioning a breastimplant between a chest wall and a pectoral muscle, c) positioning aprosthesis including a reinforcement part, a fixation part, and atransition part connecting together said reinforcement part and saidfixation part, so that a curve-shaped lower portion of the breast tissueor breast implant is received in said reinforcement part, with a loweredge of said reinforcement part facing a chest wall, and an upper areaof said fixation part facing a pectoral muscle, d) suturing the loweredge of the reinforcement part to the chest wall, e) fixing saidfixation part to said pectoral muscle, and f) closing the incision.